Why Congress quietly just gave the FDA more power

Published February 10, 2023 at 10:00 AM EST

Dr. Robert M. Califf, Commissioner of the Food and Drug Administration, during a hearing of the Senate Health, Education, Labor, and Pensions committee, examining the infant formula crisis on Capitol Hill on Thursday, May 26, 2022 in Washington, DC. (Kent Nishimura / Los Angeles Times via Getty Images)

Congress recently, and quietly, gave the FDA the power to prohibit off-label uses of medical devices.

“I think it’s a move in the right direction,” Randall Stafford says. “The FDA should be on the lookout for areas of off-label use where the benefits to harm balance is unclear and, in those cases, mandate further study.”

But others say the new authority allows the FDA to interfere with the physician-patient relationship.

They’re also concerned that the power could extend to prohibiting off label use of prescription drugs.

“That’s truly arrogant to think that the federal government is the one and only one who knows better than the physicians at the state boards of medicine about what good medicine is or what it isn’t,” Brad Thompson says.

Today, On Point: Why Congress quietly just gave the FDA more power.

Guests

Zachary Brennan, senior editor at Endpoints News, where he covers the U.S. regulatory agency. (@ZacharyBrennan)

Randall Stafford, professor of medicine at the Stanford School of Medicine.

Brad Thompson, attorney at the firm Epstein Becker Green who counsels medical device and drug product companies on FDA regulatory issues.

This article was originally published on WBUR.org.